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Insights And Tips When Addressing Bioburden Challenges Insights And Tips When Addressing Bioburden Challenges

This white paper addresses the challenges associated with the bioburden control process involved in making mAbs or other biologicals, as well as the single-use solutions and improved ways of working that manufacturers can use to avoid microbial contamination.

Bioburden: Addressing Microbial Contamination In Downstream Bioprocessing Bioburden: Addressing Microbial Contamination In Downstream Bioprocessing

A discussion on the risks related to bioburden downstream processing and ways to mitigate them. Topics covered include improvements in raw material, equipment design, and chromatography resin properties.

Liquid Filling In Hard Gelatin Capsules — Preliminary Steps
White Paper: Liquid Filling In Hard Gelatin Capsules — Preliminary Steps
On Target With Antibody Drug Conjugates

Few would dispute the fact that pharmaceutical formulation has become increasingly challenging. The difficulties all start with the ingredients used to make finished drugs. As more Active Pharmaceutical Ingredient (API) and excipient manufacturing moves offshore, particularly to India and China, there have been increasing complaints of variable quality and tightening supply. Ingredients have never officially been covered by existing pharmaceutical good manufacturing practices (GMPs), although different countries follow guidelines set by WHO, as well as ICH Q7. By Vijay Shah, Executive Director & Chief Operating Officer of Piramal Enterprises

Continuous Biomanufacturing: 10 Reasons Sponsors Hesitate

By William Whitford, Strategic Solutions Leader, BioProcess, GE Healthcare Life Sciences

The industry is abuzz with talk about continuous biomanufacturing (CB), and its virtues have been well described. Here we will look at some of the barriers or concerns perceived to limit its value to the industry. Justified or not, quite a few concerns have been expressed regarding the implementation of this new, rather disruptive technology. 

Manufacturing Process Scale-Up For Phase III

The reality is that several manufacturability problems could be brewing that will rain down during Phase III and cause costly delays, no matter how skilled the product and process may be.

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Are You Into Biosimilars?

Biosimilars are considered to be one of the fastest growing sectors of the pharmaceutical industry.

True Scientific Knowledge Management In R&D: Electronic Laboratory Notebooks (ELNs)

One tool holds a unique position among R&D informatics systems. Unlike other systems, electronic laboratory notebooks (ELNs) both produce data and consume information. An ELN’s ability to capture data, observations, experiences, and context is particularly powerful when combined with other data pipelining tools. The ability to link key pieces of data and mine experiments captured in the ELN for insights fuels true scientific knowledge management. This use case describes the broad organizational benefits that BIOVIA Workbook made possible for a global pharmaceutical company, highlighting how the system is supporting efforts to gain predictive control over key processes in Research and Development.

Medical Device Manufacturer Improves Product Quality Control

A platform’s integrated business framework helps dental implant and medical device manufacturer eliminate traditionally disconnected processes and data and increase the efficiency and accuracy of its product quality control.

Zydis® ODT - Improved Therapeutic Profile

Zydis® fast dissolve formulation for Zelapar® (Selegiline anti-Parkinson’s compound) had a positive impact on the patient compliance as compared to the Selegiline traditional tablets.

More Pharma Outsourcing App Notes & Case Studies


Outsourced Pharma provides comprehensive analysis and exclusive content from thought leaders for the advancement of global outsourcing of drug development and manufacturing. We offer readers of our website and participants of our conferences – our Outsourced Pharma community – a deeper exploration and understanding of the relationships between pharmaceutical and biotechnology organizations with their service providers, and an open channel of communication.

About Outsourced Pharma Conferences
Outsourced Pharma Conference & Exhibition is a vibrant forum for thought-leadership and the application of best practices for professionals engaged in outsourcing drug development and manufacturing. These conferences and exhibitions form a community for networking and discussing topics most relevant to sponsor-provider partnerships and supply-chain management, within an open format that promotes panel and attendee interaction.

About OutsourcedPharma.com
OutsourcedPharma.com provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and healthcare markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their bio and pharma sponsors.

Louis Garguilo Articles




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CRO Oversight Post ICH GCP E6 (R2) Addendum October 25, 2017
Live Date TBD
Duration:  60 Minutes
Price:  $299 - Includes Bonus Handouts!
The Investigational New Drug (IND) Submission - Tips to Win the First Time October 26, 2017
1pm-2:30pm EST, Online Training
Price:  $299 - Includes Bonus Handouts!
HPAPI World Congress November 1 - 2, 2017
Pharma Water Systems – Commissioning and Qualification to Ensure Compliance November 2, 2017
1:00 PM - 2:30 PM EDT
Duration:  90 Minutes
Price:  $299 – Includes Bonus handouts
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